Kornimate/medical-research-clean huggingface dataset:
fractional microneedling rf vs intralesional steroid with & without microneedling in hypertrophic scars

Conditions: Hypertrophic Scars

Summary: comparing between the effect of fractional microneedling radiofrequency versus intralesional steroid injection with and without microneedling on tissue levels of pdgf \& ctgf in hypertrophic scars

in each patient, each one of the two scars, or each side of a large scar will be assigned to one of the following treatment methods: 1-fractional microneedling radiofrequency 2-intralesional steroids injection. scars treated with intralesional steroids will be subgrouped into two groups, one group treated with only intralesional steroids and the other group treated with intralesional steroids and followed by microneedling. fractional microneedling radiofrequency parameters; power: 6 v, exposure time: 800 ms. depth: 2.5 mm (using non-insulated micro-needles), frequency: 2 hz. for intralesional steroids injection, triamcinolone acetonide will be injected in concentration 1:2 (20 mg/dl) using insulin syringe. microneedling will be done using the same tip of the fractional microneedling radiofrequency at same depth. all patients will receive 5 treatment sessions 4 weeks apart.

Eligibility criteria:
inclusion criteria: * patients with mature hypertrophic scars. * patients with age above 18 years. * both males and females. * patients with two separate lesions, each 3 cm length at least or a large sized lesion 10 cm length at least. exclusion criteria: * patients with unrealistic expectations. * patients with active skin infections or autoimmune diseases. * non-compliant patients. * patients who had received any form of treatment for scars during the last six months. * recent use of isotretinoin within six months prior to the procedures. * patient with known allergy to lidocaine. * pregnancy \& lactation.
a phase ii study of crt combined with ql1706 in escc patients

Conditions: Esophageal Squamous Cell Carcinoma

Summary: this is a single arm, multi-center phase ii study. this clinical study is an investigator-initiated clinical trial（iit). the objective of this study is to evaluate the efficacy and safety of chemoradiationtherapy combined with ql1706 (anti-ctla-4 and pd-1 antibody) in patients with unresectable locally advanced esophageal squamous cell carcinoma.


Eligibility criteria:
inclusion criteria: 1. subjects participate voluntarily and sign informed consent. 2. age:18-75 years, male or female. 3. histologically confirmed advanced unresectable esophageal squamous cell carcinomas,unresectable of clinical stage ii-iva patients (include unresectable,or surgical contraindication or refuse surgery)(according to ajcc 8th edition stage , pre-treatment clinical stage ct1n2-3m0,ct2-4bn0-3m0. 4. at least 1 measurable target lesion and/or unmeasurable target lesion according to response evaluation in solid tumors (recist 1.1). exclusion criteria: 1. patients who have a history of esophageal cancer surgery. 2. previous history of fistula caused by primary tumor infiltration. 3. a high risk of gastrointestinal bleeding, esophageal fistula or esophageal perforation. 4. subjects with poor nutritional status and weight loss of ≥ 10% in the first 2 months of screening have no significant improvement after nursing intervention. 5. major surgery or serious trauma within 4 weeks before the first use of the study drug.

Keywords: esophageal cancer concurrent chemoradiation immunotherapy ctla-4 pd-1 ql1706
treatment of osteoporosis - top 2-5 clinical studies (pear control)

Conditions: Osteoporosis

Summary: due to the fact that bone mineral density (bmd) is a not enough sensitive parameter for assessment of the bone quality and that the changes in bmd are gradually, extension of the clinical follow up is recommended. on that way the result will be more reliable. therefore the protocol "top 2-5" is the extension of top 1-study with a slight change of the study design. all subjects will be treated with panaceo. it will be a "pear control", where the patient is control to himself, or herself (each patient from "placebo group (top1) can be compared after further years of threatment. additionally, extension of the follow up will provide an assessment of the fracture risk in a more reliable manner, which is considered as the most preferably outcome in majority clinical studies of osteoporosis treatment, because it is the most important requirement for the acceptance by the regulatory agencies (fda, ema).

pear control study over 4 supplementation years. study population: the study population will consist of patients from a previous study (start: 100 and drop out rate) with osteoporosis defined according bmd (bone mineral density) criteria: t score -2, 5 on the femoral neck, and, or t -2, 5 on l1-l5, who has not been treated before, or in whom privies treatment did not been successful, despite a gender or age. subjects will receive pma-zeolite . demonstration of efficacy of panaceo in the treatment of osteoporosis by increasing bone mineral density and reduction of fracture risk. demonstration of efficacy of panaceo in the treatment osteoporosis despite of the gender and cause. demonstration of efficacy of panaceo in the patients who was on drug treatment (bisfosfonates or serm) more than five years without significant improvement or those who are suspected on the bone turnover over-suppression. tolerability safety (adverse events, vital signs, clinical chemistry)

Eligibility criteria:
inclusion criteria: * 100 subjects with osteoporosis among those, as a subgroup, 20 subjects with diabetes type 2 and osteoporosis; the osteoporosis- was diagnosed by standard dxa measurement (bmd t-score: - 2.5 or below ) exclusion criteria: * chronic renal failure, secondary osteoporosis
treatment of post sphincterotomy-bleeding by epinephrine-injection versus insertion of an plastic stent

Conditions: Endoscopic Biliary Sphincterotomy; Bleeding

Summary: post sphinterotomy-bleeding (psb) occurs in 1-2 % of endosocpic retrograde cholangiopancreaticography (ercp) and usually needs no blood transfusion after endoscopic therapy but can be life-threatening in some rare cases. there are no prospective comparative studies concerning the endoscopic treatment of psb due to the rarity of the incident. insertion of an endoprosthesis in the common bile duct may be more effective than epinephrin-injection into the papilla which is the therapy of first choice. a retrospective single centre analysis on both used methods over a study period of 16 years shall be performed.

post sphinterotomy-bleeding (psb) occurs in 1-2 % of endosocpic retrograde cholangiopancreaticography (ercp) and usually needs no blood transfusion after endoscopic therapy but can be life-threatening in some rare cases. the increasing use of antiplatelet and/or anticoagulant therapies enhances the risk of psb. there are no prospective comparative studies concerning the endoscopic treatment of psb due to the rarity of the incident. insertion of an endoprosthesis in the common bile duct may be more effective than epinephrin-injection into the papilla which is the therapy of first choice. a retrospective single centre analysis on both used methods over a study period of 16 years shall be performed. in detail, clinical success and safety of the procedure, re-bleeding rate, number of re-interventions and days of hospital stay will be analysed.

Eligibility criteria:
inclusion criteria: * post sphincterotomy bleeding (psb) of the papilla (time frame: from procedure up to ten days after the procedure) * treatment of psb by epinephrine-injection or insertion of a plastic stent into the common bile duct exclusion criteria: * pregnant and/or lactating women * complete patient record is not available

Keywords: endoscopic biliary sphincterotomy endoscopic retrograde cholangiopancreatography bleeding epinephrine stent
part a: efficacy and safety of aevi-001 in children and adolescents with adhd and with mglur mutations

Conditions: Attention Deficit Hyperactivity Disorder

Summary: this is part a of a 2-part, 6-week, double-blind, dose-optimization, parallel-group study in children and adolescents (ages 6-17 years) with adhd with and without cnvs in specific genes implicated in glutamatergic signaling and neuronal activity. parts a will include subjects determined to have a specific gene mutations implicated in glutamatergic signaling and neuronal connectivity.


Eligibility criteria:
inclusion criteria: 1. subject and parent/legally authorized representative (lar) can speak english fluently and have provided written informed consent, and assent (as applicable) for this study. 2. subject is 6 to 17 years of age (inclusive) at the time of consent/assent. the date of signature of the informed consent/assent is defined as the beginning of the screening period. this inclusion criterion will only be assessed at the screening visit (visit 1). 3. subject is male or non-pregnant, non-lactating female, who if of childbearing potential agrees to comply with any applicable contraceptive requirements prior to administration of investigational product (ip). 4. subject meets diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criteria for a primary diagnosis of adhd based upon dsm 5 criteria. 5. subject has a minimum score of ≥28 on the adhd-rs-5 at the baseline visit (visit 2). 6. subject has been genotyped previously and has their identity confirmed (if required). exclusion criteria: 1. subject or parent/lar is, in the opinion of the investigator, mentally or legally incapacitated, has significant emotional problems at the time of the screening visit (visit 1) which could interfere with the conduct of study evaluations. 2. subject has a current, controlled or uncontrolled, co-morbid major psychiatric diagnosis (aside from adhd), including an anxiety disorder, major depression, bipolar disease, schizophrenia (or any psychotic disorder), and moderate or severe intellectual disability. mild anxiety and/or depressive symptoms that do not meet diagnostic criteria for an anxiety disorder or major depression and/or do not require treatment are not exclusionary. 3. subject has autism spectrum disorder to include a dsm-iv diagnosis of autistic disorder, asperger's disorder, or pervasive developmental disorder. 4. subject is currently taking any medication that might confound the results of safety assessments conducted in the study. 5. subject has a known history of cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, cardiac conduction problems, exercise-related cardiac events including syncope and pre-syncope, or other serious cardiac problems. 6. subject has any clinically significant abnormality on 12-lead ecg performed at the screening visit (visit 1) and/or the baseline visit (visit 2) such as serious arrhythmia, cardiac conduction problems, or other abnormalities deemed to be a potential safety issue.
evaluation of post operative pain in retreatment of molars using different irrigant

Conditions: Root Canal Infection

Summary: this study evaluates the efficacy of dexamethasone as a intracanal irrigant along with sodium hypochlorite 1% and 5.25% concentrations in post treatment pain for molar root canal retreatment.

main objective of root canal retreatment is to alleviate pain and disinfect the rootcanal .however some patients may experience mild to severe pain following treatment , which leads to intake of painkillers orally for post operative pain management. so , this study evaluates the efficiency of dexamethasone used as intracanal irrigant in post treatment pain for molar root canal retreatment sodium hypochlorite (1% \&5.25%) is used for disinfecting the canals patients will be grouped into symptomatic and asymptomatic patients requiring root canal retreatment and irrigants will be used in various combinations as mentioned below 1. 1% sodium hypochlorite alone 2.5ml in each canal along with ultrasonic activation 2. 1% sodium hypochlorite and dexamethasone 4mg,2.5ml in each canal along with ultrasonic activation 3. 5.25% sodium hypochlorite alone 2.5ml in each canal along with ultrasonic activation 4. 5.25% sodium hypochlorite and dexamethasone 4mg, 2.5ml in each canal along with ultrasonic activation calcium hydroxide is commonly used as intracanal medicament in all the patients post operative symptoms is evaluated at 12 hrs , 24 hrs,48 hrs, 72 hrs and 1 week followed by obturation is completed

Eligibility criteria:
inclusion criteria: * teeth previously treated or attempted root canal treatment, * teeth with or without symptoms, * periapical radiograph showing evidence of inadequate previous root canal treatment or periapical changes, * only teeth or at least one canal where complete removal of root canal filling material was possible and reach the working length in first appointment. exclusion criteria: * patient not willing for follow up, * teeth with extensive cervical or apical resorption that restricted the use of sodium hypochlorite irrigation, * teeth with poor periodontal status, teeth not suitable for post endodontic restoration, * patients with acute periapical abscess, * patients with systemic conditions preventing radiograph exposure or multi visit treatment, * pregnant patients, * patients with allergy to any known dental materials.
superior vena cava isolation plus pulmonary vein isolation for paroxysmal atrial fibrillation

Conditions: Atrial Fibrillation

Summary: pulmonary vein isolation (pvi) for paroxysmal atrial fibrillation (paf) has limited success. the superior vena cava (svc) has been identified as one of the most common non-pulmonary vein triggers for paf. it is estimated that svc isolation (svci) could improve the clinical results of patients with paf. however, results from previous studies about svci remain controversial. safety concerns for svci may outweigh its benefits and lead to inadequate ablation. to address this issue, the introduction of a quantitative ablation index (ai) for svci may provide a solution. therefore, the investigators sought to initiate a retrospective, multi-center study, to explore the efficacy and safety of quantitative svci in addition to pvi in paf.

catheter ablation has emerged as an effective treatment for drug-refractory paf and is recommended as first-line therapy by current guidelines. pvi is considered the cornerstone of catheter ablation for atrial fibrillation (af). however, despite persistent pvi, a subgroup of patients may experience recurrent af due to focal ectopic discharges originating outside the pulmonary veins. among the non-pulmonary vein triggers, the svc stands out as a common culprit, making it a promising ablation target for maintaining sinus rhythm. nevertheless, results from previous studies that evaluated the efficacy of svci showed conflicting results. one possible explanation is that svc is adjacent to critical anatomical structures (such as the sinus node and the phrenic nerve), which raises safety concerns and often leads to inadequate ablation. therefore, it is necessary to establish a standardized ablation procedure for svci, ensuring both safety and efficacy. to address this issue, the investigators proposed the concept of "quantitative ablation for svci." by introducing ai as a quantitative measure, it is possible to achieve precise catheter ablation while minimizing the risk of procedure-related complications. this study aimed to investigate the safety and feasibility of quantitative ai-guided svci in addition to pvi. participants with paf who required catheter ablation will be consecutively enrolled in three hospitals in china.

Eligibility criteria:
inclusion criteria: * symptomatic paroxysmal af that are unresponsive to antiarrhythmic drugs (one or more than one). * willing to undergo catheter ablation for af. exclusion criteria: * history of any type of catheter ablation for cardiac arrhythmias. * sinus node dysfunction that requires permanent pacemaker implantation.
a study of chicory for treatment of osteoarthritis of the hip or knee

Conditions: Osteoarthritis

Summary: extracts of chicory root have anti-inflammatory properties in vitro and in animal models of arthritis. the primary objective of this investigator-initiated, phase 1, placebo-controlled, double blind, dose-escalating trial is to determine the safety and tolerability of a proprietary bioactive extract of chicory root in patients with osteoarthritis (oa). secondary objectives are to assess effects on the signs and symptoms of this disorder. individuals greater than 50 years of age with oa of the hip or knee will be eligible for trial entry.


Eligibility criteria:
inclusion criteria: 1. patients must be 50 years of age or older and may be of either gender. 2. patients must have have an imaging-confirmed (radiograph or mri) diagnosis of oa of the hip or knee. 3. patients must not have taken a nonsteroidal anti-inflammatory medication for at least 7 days prior to the baseline visit (a single daily aspirin 325 mg or less is allowed throughout the study). 4. patients must be able and willing to give informed consent. exclusion criteria: 1. any unstable comorbid medical condition that in the opinion of the investigator could interfere with the ability of the patient to complete the study. 2. patients who are unable to ambulate and require a wheelchair due to the severity of the arthritis are excluded. ambulatory aids such as canes and walkers are acceptable. 3. patients requiring continuing therapy with nonsteroidal anti-inflammatory drugs are excluded. 4. patients requiring any dose of glucocorticoids within the past 30 days are excluded.
reduction of topical anesthetic time for subcutaneous port access using ultrasound

Conditions: Pain

Summary: children ages 3-17 who are undergoing port access receive both standard care, topical medicine for numbing (lmx4), and the study intervention which utilizes ultrasound to speed the onset of lmx4 from 30 minutes to 5 minutes. the procedures will be performed on 2 separate visits to the clinic. the child's pain with the access procedure is evaluated.


Eligibility criteria:
inclusion criteria: * children ages 3-17 with subcutaneous port exclusion criteria: * emergent need for port access * allergy to lidocaine sodium lauryl sulfate
azd3355 dose-escalation study in healthy males

Conditions: Reflux Disease

Summary: the aim is to establish the maximal tolerated dose of azd3355 for the selection of doses in the up-coming studies. this will be done by comparing single and repeated doses of azd3355 to placebo ("inactive substance"). safety and tolerability variables will be closely monitored throughout the study.


Eligibility criteria:
inclusion criteria: * subjects without concurrent diseases who do not require any medical treatments * provision of signed informed consent. exclusion criteria: * history of somatic disease/condition, which may interfere with the objectives for the study, as judged by the investigator. * clinically significant illness or clinically relevant trauma within the 2 weeks prior to the administration of the investigational product, as judged by the investigator. * history of clinically significant orthostatic reaction or syncope * clinically important abnormalities related to the heart function

Keywords: safety tolerability healthy subjects
sarcopenia and diabetes mellitus

Conditions: Sarcopenia

Summary: the association of diabetes mellitus type 2 (t2dm) with sarcopenia has not been adequately investigated. sarcopenia is characterized by progressive and generalized loss of skeletal muscle mass which may affect performance.

the relationship between dm and sarcopenia has not been extensively investigated. skeletal muscle is the primary site of glucose deposition, and decreased muscle mass plays a role in impaired glucose metabolism in patients with insulin resistance and type 2 diabetes. skeletal muscle resistance to insulin action appears to be the link between type 2 diabetes (t2dm) and sarcopenia. hyperglycemia is a metabolic dysfunction which can potentially damage muscle cells. insulin deficiency leads to marked muscle catabolism that can be reversed by exogenous insulin administration. the metabolic disorder in diabetics may be reversible.thus, it may be possible to restore physical ability by restoring the musculoskeletal system.therefore, the diagnosis of sarcopenia if made can lead to interventions which may prevent the deterioration of body composition and the subsequent deterioration of quality of life. according to the results of the aforementioned studies it is still inconclusive if the metabolic disorder in diabetes may be related to sarcopenia, or sarcopenia may be a consequence of diabetes.

Eligibility criteria:
inclusion criteria: * t2dm participants were on treatment with oral hypoglycemic agents * confirmation criteria of a t2dm diagnosis were glycosylated hemoglobin a1c levels ≥ 6.5% and fasting plasma glucose ≥ 126 mg/dl (7 mmol/l). exclusion criteria: * history of a cerebrovascular event, a heart stent, an artificial cardiac pacemaker or other metallic implant, * a malignant tumor, liver disease, end stage chronic kidney disease, a thyroid disorder, carpal tunnel syndrome, * subjects who received special dietary supplements such as protein powder, during the last three months were excluded from the study.

Keywords: sarcopenia diabetes mellitus skeletal muscle index
flt-pet / mri brain mets

Conditions: Brain Metastases; Radionecrosis

Summary: brain metastasis (brm) develops in approximately 40% of cancer patients. stereotactic radiosurgery (srs) is a form of radiotherapy that delivers high-dose per fraction to individual lesions that is commonly used to treat brm. radionecrosis (rn) is an adverse event that occurs in approximately 10 - 25% of patients 6 - 24 months after treatment with srs. tumour progression may also occur due to local failure of treatment. radionecrosis and tumour progression share very similar clinical features including vomiting, nausea, and focal neurologic findings. radionecrosis and tumour progression also share overlapping imaging characteristics. due to their similarities, physicians need to perform a surgical resection to diagnose the complication. by using a hybrid flt-pet/mri scan, the investigators propose that this combination scan will provide robust data with which to differentiate between radionecrosis and tumour progression without the need for surgery. the investigators plan to conduct a single center feasibility study to investigate the potential in differentiating between srs and tumour progression in patients, including those who may have previously undergone srs for brm, who are suspected to have either rn or tumour progression using hybrid flt-pet/mri imaging.


Eligibility criteria:
inclusion criteria: 1. 18 years or older 2. previously treated with srs for brm 3. new intracranial lesion with clinical and radiographic findings suspicious for either rn or tumour progression 4. may be planned surgical resection of the lesion in question. the determination that the lesion is appropriate for and may require surgical resection will be made by the multi-disciplinary brain metastasis team. surgery is preferred but not required. if a patient is planned for surgery, the date does not need to be established and the patient does not need to have consented in order to be eligible for this study, however the imaging procedure will need to occur prior to the date of surgery. 5. a negative serum pregnancy test within the two-week interval immediately prior to pet-mri imaging for women of child-bearing age 6. ability to provide written informed concern to participate in the study exclusion criteria: 1. previous radiotherapy to the intended treatment volume 2. active malignancy other than sarcoma 3. inability to remain supine for at least 60 minutes 4. pregnancy or breast feeding 5. age \<18 years 6. failure to provide written informed consent 7. contraindication for mri as per current institutional guidelines